Fitting of Commonly Available Face Masks for Late Preterm and Term Infants (CAFF)

May 29, 2019 updated by: University Hospital Tuebingen

Around ten percent of newborn infants require positive pressure ventilation (PPV) in the delivery room. This is most commonly delivered using a round or anatomically shaped face mask attached to a T-piece device, self-inflating bag or flow-inflating bag. Face mask ventilation is a challenging technique and difficult to ensure that an appropriate tidal volume is delivered because large and variable leaks occur between the mask and face.

It is recommended by International Guidelines to start with mask ventilation by placing a fitting face mask on the babies face.

A fitting face mask covers the mouth and nose. A non-fitting overlaps the eyes and the chin, which causes a airleak. Studies report variable leak, sometimes more than 50% of inspiratory volume, during PPV in preterm infants in the delivery room. The presence of a large leak may lead to ineffective ventilation and an unsuccessful resuscitation.

A study performed in preterm infants showed that most masks available are too big for the majority of those infants.

The investigators hypothesis is that the commonly available face masks for term infants are similarly too big for some term and late preterm infants (≥ 34 weeks gestation).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators would like to measure the dimensions of the faces of late preterm and term infants (≥ 34 SSW) within the first 72 hours of life and compare this data with the size of the most recommended available face masks:

VBM Germany:

external diameter smaller mask: 50 mm, external diameter bigger mask: 70 m

Laerdal:

external diameter smaller mask: 50 mm; external diameter bigger mask: 60 mm

Fisher&Paykel:

external diameter smaller mask: 50 mm; external diameter bigger mask: 60 mm

Therefore the investigators want to collect the following information from the participants:

Picture of the participant´s face (2D and 3D-Image) birth weight, head circumference, mode of delivery, gestational age, singletons/ twins/ triplets, date of birth

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tuebingen, Germany, 72072
        • University Clinic Tuebingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 days (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • Late preterm and term infants, gestational week ≥ 34 +0
  • 10 to 15 patients in every gestational-week
  • born at the University Hospital of Tuebingen
  • signed declaration of consent from the parents
  • ≤ 72 hours

Description

Inclusion Criteria:

  • Late preterm and term infants, gestational week ≥ 34 +0
  • born at the University Hospital of Tuebingen
  • signed declaration of consent from the parents
  • ≤ 72 hours

Exclusion Criteria:

  • congenital facial anomalies
  • any respirators or other medical device that covers the face
  • missing declaration of consent from the parents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
2d and 3D image
A 2D and 3D image of the participants' face will be taken. It will at least last 2-3 sec.
Other: 2D and 3D image of infants´ faces
2D and 3D image of infants´ faces

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mouth: Find out the best fitting facemask
Time Frame: 1 year
Measure distance in millimeters with ImageJ and 3DMaxSoftware from the nasofrontal groove to the mental protuberance and determine if the commonly available face masks fit this study population.
1 year
Lips: Find out the best fitting facemask
Time Frame: 1 year
Measure the lateral points located at each labial commissure in millimeters with ImageJ and 3DMaxSoftware and determine if the commonly available face masks fit this study population.
1 year
Eyes: Find out the best fitting facemask
Time Frame: 1 year
Measure the points at the inner commissure of the eye fissure in millimeters with ImageJ and 3DMaxSoftware and determine if the commonly available face masks fit this study population.
1 year
Chin: Find out the best fitting facemask
Time Frame: 1 year
Measure length of the chin in millimeters with ImageJ and 3DMaxSoftware and determine if the commonly available face masks fit this study population.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gestational age
Time Frame: 1 year
Correlation between gestational age and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware.
1 year
Birth weight
Time Frame: 1 year
Correlation between birthweight and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware.
1 year
headcircumference
Time Frame: 1 year
Correlation between headcircumference and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware.
1 year
gender: male/female
Time Frame: 1 year
Correlation between gender (male/female) and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware.
1 year
way of delivery: spontaneous/cesarean
Time Frame: 1 year
Correlation between way of delivery and distance from the nasofrontal groove to the mental protuberance measured in millimeters with ImageJ and 3DMaxSoftware..
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2018

Primary Completion (Actual)

January 30, 2019

Study Completion (Actual)

January 30, 2019

Study Registration Dates

First Submitted

November 24, 2017

First Submitted That Met QC Criteria

December 4, 2017

First Posted (Actual)

December 11, 2017

Study Record Updates

Last Update Posted (Actual)

May 30, 2019

Last Update Submitted That Met QC Criteria

May 29, 2019

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAFF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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